Specific monoclonal antibody against the N antigen of human respiratory syncytial virus (hRSV) useful for treating infection, detection thereof and diagnosis

Abstract

The invention relates to a monoclonal antibody or fragment thereof, which recognizes the N (nucleocapsid) protein of the human respiratory syncytial virus (RSV), useful for the development of diagnostic methods for RSV infection and for the production of pharmaceutical compositions intended for the treatment, protection and/or prophylaxis of RSV infection.

The invention claimed is: 
     
       1. A monoclonal antibody or a fragment thereof that binds to a nucleoprotein protein N of a human respiratory syncytial virus (RSV), wherein said antibody or fragment thereof has a variable region of a heavy chain whose CDR1, CDR2 and CDR3 have amino acid sequences comprising the amino acid sequence SEQ ID No:5, SEQ ID No:6, and SEQ ID No: 7, respectively, and at the same time has a variable region of a light chain whose CDR1, CDR2, and CDR3 have amino acid sequences comprising the amino acid sequence SEQ ID No: 11, SEQ ID No: 12, and SEQ ID No: 13, respectively. 
     
     
       2. The monoclonal antibody or a fragment thereof that binds to the nucleoprotein protein N of RSV according to  claim 1 , wherein the antibody has a variable region of the heavy chain whose CDR1, CDR2, and CDR3 are encoded by sequences comprising the nucleic acid sequence SEQ ID No:8, SEQ ID No:9, and SEQ ID No: 10, respectively, and their respective complementary reverse sequences and has a variable region of the light chain whose CDR1, CDR2, and CDR3 are encoded by sequences comprising the nucleic acid sequence SEQ ID No:14, SEQ ID No: 15, and SEQ ID No: 16, respectively, and their respective complementary reverse sequences. 
     
     
       3. The monoclonal antibody or a fragment thereof that binds to the nucleoprotein protein N of RSV according to  claim 1 , wherein the antibody is a humanized or chimeric antibody. 
     
     
       4. A pharmaceutical composition for a treatment and/or a prophylaxis of infection caused by a human respiratory syncytial virus (RSV), wherein the composition comprises the monoclonal antibody or a fragment thereof that binds to the nucleoprotein protein N of RSV of  claim 1  and a pharmaceutically acceptable carrier. 
     
     
       5. A method for detection of human respiratory syncytial virus (RSV) in a sample, comprising
 contacting the sample with the monoclonal antibody or a fragment thereof that binds to the nucleoprotein protein N of RSV of  claim 1 ; and 
 detecting a binding of the antibody to the antigen. 
 
     
     
       6. The method according to  claim 5 , wherein the method used to detect the binding of the antibody to the antigen is selected from the group consisting of ELISA, immunofluorescence, immunohistochemistry, immunochromatography, flow cytometry, cell sorter, immunoprecipitation, and Western blot. 
     
     
       7. A method for detection of human respiratory syncytial virus (RSV) in a sample, comprising:
 contacting the sample with a monoclonal antibody or a fragment thereof that binds to a nucleoprotein protein N of RSV; and 
 detecting the binding of the antibody to the antigen, 
 wherein the monoclonal antibody or a fragment thereof is the monoclonal antibody or a fragment thereof according to  claim 1  and is conjugated with a marker which allows its detection. 
 
     
     
       8. The method according to  claim 7 , wherein the antibody or a fragment thereof is conjugated with a marker selected from the group consisting of fluorophores, biotin, radioisotopes, metals, and enzymes. 
     
     
       9. The method according to  claim 8 , wherein the antibody or a fragment thereof is immobilized on a solid support. 
     
     
       10. The method according to  claim 9 , wherein a material of the solid support is selected from the group consisting of nitrocellulose, cellulose, polyethylene, and nylon. 
     
     
       11. A method of treatment or prophylaxis of human respiratory syncytial virus (RSV) and development of a disease caused by the virus, in a subject exposed to the virus, comprising administering the pharmaceutical composition of  claim 4  to the subject. 
     
     
       12. The method of  claim 11 , wherein the composition is administered intramuscularly.